PhysioMG Spzoo - User Guide v10 - 0 02-09-2019

PhysioMG –
User Manual
1. Basic information and contents
Contents
1. INTRODUCTION .......................................................................................................................................................5
1.1 MANUFACTURER .............................................................................................................................................................
5 1.2 RISK MANAGEMENT
PROCESS .............................................................................................................................................. 5
2. INTENDED USE .........................................................................................................................................................6

2.1 INTENDED USERS ..............................................................................................................................................................
6 2.2 USER TRAINING
............................................................................................................................................................... 7
3. WARRANTY AND MANUFACTURER'S RESPONSIBILITY..............................................................................................8
4. OPERATIONAL SAFETY .............................................................................................................................................9
4.1 MAINS SUPPLY AND OPERATION MODE ..................................................................................................................................
9 4.2 STORAGE, OPERATION AND TRANSPORT CONDITIONS ................................................................................................................ 9
4.3 WARNINGS AND SAFETY NOTES ........................................................................................................................................
9 4.4 APPLIED PARTS AND WORKING TEMPERATURE ....................................................................................................................... 12
4.5 EXPLOSION PROOF ENVIRONMENT ......................................................................................................................................
12 4.6 ELECTROMAGNETIC ENVIRONMENT ....................................................................................................................................
12 4.7 OPERATION OF TOUCH-SENSITIVE DISPLAYS .......................................................................................................................... 13
4.8 TECHNICAL SUPERVISION ..................................................................................................................................................
13 4.9 DISPOSAL .....................................................................................................................................................................
14
5. UNIT DESCRIPTION ................................................................................................................................................15
5.1 GENERAL CHARACTERISTICS ..............................................................................................................................................
15 5.2 KEYBOARD....................................................................................................................................................................
16 5.3 MAGNETIC FIELD APPLICATORS .......................................................................................................................................... 17
5.4 NAME PLATES ...............................................................................................................................................................
19
6. DEVICE INSTALLATION AND START-UP ...................................................................................................................20
6.1 INSTALLATION ...............................................................................................................................................................
20 6.1.1 Connection of magnetic field applicators....................................................................................................... 20
6.1.2 First operation................................................................................................................................................ 22
6.2 SETUP MODE.................................................................................................................................................................
22 6.2.1 Basic information ........................................................................................................................................... 22
6.2.2 Language ....................................................................................................................................................... 22
6.2.3 Global settings ............................................................................................................................................... 23
6.2.4 Functional settings......................................................................................................................................... 23
6.2.5 Service ............................................................................................................................................................ 24
6.2.6 Statistics......................................................................................................................................................... 25
6.3 TRANSPORT POSITION .....................................................................................................................................................
25 6.3.1 Couch ............................................................................................................................................................. 25
6.3.2 The stand with CP applicator ......................................................................................................................... 25
6.3.3 Trolley for applicators .................................................................................................................................... 25
7. UNIT OPERATION...................................................................................................................................................27
7.1 PATIENT PREPARATION AND TREATMENT PERFORMANCE ......................................................................................................... 27
7.1.1 General information....................................................................................................................................... 27
7.1.2 Magnetotherapy ............................................................................................................................................ 27
7.2 SCREEN CONFIGURATION .................................................................................................................................................
28 7.3 GENERAL CONFIGURATION
............................................................................................................................................... 29 7.3.1 Treatment
channel configuration – for two-channel models......................................................................... 29 7.3.2 Channel
selection tabs ................................................................................................................................... 29 7.4 DISPLAY
DESCRIPTION ..................................................................................................................................................... 30 7.5 DUAL
MODE ................................................................................................................................................................. 31 7.6
APPLICATION OF MAGNETIC FIELD ...................................................................................................................................... 32 7.7
OPERATION WITH PRESET TREATMENT PROGRAMS ................................................................................................................. 33 7.8
FAVORITE PROGRAMS ..................................................................................................................................................... 35 7.9
MANUAL MODE OPERATION ............................................................................................................................................. 35 7.10
USER PROGRAMS ...................................................................................................................................................... 35 7.11
USER SEQUENCES ...................................................................................................................................................... 37 7.12
SAFE SHUTDOWN PROCEDURE ...................................................................................................................................... 39
8. DEFINITIONS AND PARAMETERS............................................................................................................................40
8.1 GENERAL INFORMATION ..................................................................................................................................................
40 8.2 TREATMENT
PARAMETERS ................................................................................................................................................ 40 8.2.1 The
mode of magnetic field generation ......................................................................................................... 42 8.2.2
Spectrum ........................................................................................................................................................ 43
Page 3 / 58 Issue date 02.09.2019, release 10.0

8.3 LIMITATION OF INDUCTION WITH FREQUENCY INCREASE .......................................................................................................... 44

9. INDICATIONS AND CONTRAINDICATIONS...............................................................................................................46
9.1 INDICATIONS .................................................................................................................................................................
46 9.2 CONTRAINDICATIONS ......................................................................................................................................................
46 9.3 POSSIBLE SIDE EFFECTS ....................................................................................................................................................
47
10. MAINTENANCE, CLEANING, DISINFECTION.............................................................................................................48
10.1 CLEANING OF TOUCHSCREEN .......................................................................................................................................
48 10.2 CLEANING OF THE UNIT AND APPLICATORS CASINGS ........................................................................................................... 48
10.3 DISINFECTION ..........................................................................................................................................................
48 10.4 SPECIAL MESSAGES ....................................................................................................................................................
49 10.5 SELF-TEST PROCEDURE ...............................................................................................................................................
49 10.6 TROUBLESHOOTING ...................................................................................................................................................
50 10.7 FUSE REPLACEMENT ..................................................................................................................................................
50
11. SPECIFICATION AND ACCESSORIES.........................................................................................................................52
11.1 TECHNICAL DATA ......................................................................................................................................................
52 11.2 EMC PARAMETERS ...................................................................................................................................................
54 11.3 STANDARD ACCESSORIES ............................................................................................................................................. 56
11.4 OPTIONAL ACCESSORIES .............................................................................................................................................
56
12. APPENDIX A. SYMBOL DESCRIPTION ......................................................................................................................57
List of illustrations and tables

Figure 4.1. A label informing about the temperatures of the solenoid applicators .................................................................
12 Figure 5.1 General view of the PhysioMG
827 ......................................................................................................................... 15 Figure 5.2. General view of PhysioMG
825 and 815 units........................................................................................................ 15 Figure 5.3 Arrangement of keyboard
components on the example of PhysioMG 827 ............................................................ 16 Figure 5.4 CS35, CS60 and CS75
solenoid applicators .............................................................................................................. 17 Figure 5.5 View of the
controller and solenoid applicator with a couch.................................................................................. 17 Figure 5.6. CS35
applicator on the trolley ................................................................................................................................ 18 Figure 5.7. CP
applicators on a stand ....................................................................................................................................... 18 Figure 5.8.
CPEP applicators ..................................................................................................................................................... 19 Figure 6.1
View of the PhysioMG 827 sockets label................................................................................................................. 20 Figure
6.2 View of the PhysioMG 825 sockets label................................................................................................................. 21
Figure 6.3 View of the PhysioMG 815 sockets label.................................................................................................................
21 Figure 6.4. Incorrectly connected
applicator............................................................................................................................ 22 Figure 6.5 Screen view – date
and time edition ....................................................................................................................... 23 Figure 6.6. Transport
position of the trolley ............................................................................................................................ 26 Figure 7.1 Field
description ...................................................................................................................................................... 28 Figure 7.2
Location of channel selection tabs .......................................................................................................................... 29 Figure
7.3. An example of the appearance of a treatment screen for magnetotherapy treatment – a single applicator ....... 30 Figure
7.4. An example of the appearance of a treatment screen for magnetotherapy treatment – dual mode ................... 31 Figure
7.5. View of the parameters edit screens in dual mode................................................................................................ 31 Figure
7.6 Examples of magnetic field application ................................................................................................................... 32
Figure 7.7 Samples view of the information screen .................................................................................................................
33 Figure 8.1. Manual frequency
setting....................................................................................................................................... 42 Figure 8.2. Manual time
setting ............................................................................................................................................... 42 Figure 8.3. Single-half
wave...................................................................................................................................................... 42 Figure 8.4. Double-
half wave.................................................................................................................................................... 43 Figure 8.5.
Frequency spectrum............................................................................................................................................... 43 Figure
8.6. Decrease in induction value with frequency increase ............................................................................................ 45
Table 1. Available models of the PhysioMG unit........................................................................................................................

6 Table 2. Recommendations for the operation of touch screens ..............................................................................................
13 Table 3. Permissible configurations of applicators in the sockets of various models of PhysioMG .........................................
21 Table 4. Signaling special messages
......................................................................................................................................... 49 Table 5. The "hardware" error
coding system.......................................................................................................................... 49
User Manual – PhysioMG Page 4 / 58
1. Introduction
Read this Guide carefully before starting the unit operation! Follow the recommendations
presented in this Guide! This user guide refers to model 815, 825 and 827 of the unit.
Model of the unit can be found on the name plate.
The Physio MG unit should be installed and started off by the seller.
The recipient has the right to insist on the product operation training.
The unit may only be operated by qualified personnel or under supervision of such personnel!
WARNING: The device is intended for adult patients only. It is not intended for use in a home
healthcare environment.
Description of symbols used in this manual:
Read appropriate passage of this user guide, warnings or important information. Failure to
observe warnings can lead to injuries.
Important notices and information.
Following texts marked with this symbol facilitates device operation.
NOTE:
The outlook of screens shown in this manual may slightly differ from their actual outlook during device
operation. These differences may concern size and type of fonts and size of symbols. There are no
differences in the content of shown information.
WARNING: No modification of this equipment is allowed!
1.1 Manufacturer
ASTAR Sp. z o.o.
UL. ŚWIT 33
43-382 BIELSKO-BIAŁA, POLAND
www.astar.eu
1.2 Risk management process
The manufacturer conducts continuous risk management process referring to the device construction, its
intended use, method of operation and maintenance. Residual risks are presented in this User Manual in form
of information about precautions, contraindications and warnings.

2. Intended use
2. Intended use
The PhysioMG unit is an active, non-invasive therapeutic device, intended for carrying our treatment
procedures using low frequency magnetic field generated by dedicated applicators.
The magnetic field can be used to treat conditions in the following areas:
• orthopedics,
• sports medicine,
• aesthetic medicine,
• rheumatology,
• neurology,
• urology,
• dermatology,
• angiology,
• gynecology,
• stomatology.
A list of indications and contraindications is given in Chapter 9.
When characterizing the biological effects of low frequency magnetic field, first of all it is necessary to
mention:
• modification of cellular signal transmission,
• effects on the structure of biological membranes and the processes of ions' transportation,
• effects on the processes of nucleic acid replication and transcription as well as protein synthesis,
• effects on cell proliferation processes,
• effects on oxygen free radicals and cell apoptosis processes,
• regenerative effects,
• osteogenetic effects,
• anti-inflammatory effects,
• analgesic effects.
The unit possesses the base of preset treatment procedures along with therapeutic encyclopedia,
which significantly increases comfort of operation. There is also a possibility to create own user-defined
programs and sequences.
Complete medical product features:

• PhysioMG controller,
• LE_CS type couch,
• ST_CS type trolley for applicators,
• stand for type CP applicator,
• solenoid applicators,
• plate applicators.
Available functionality depends on the model of the unit – for details, see Table 1.
Table 1. Available models of the PhysioMG unit
Number of Applicable applicators

LCD touch
Model treatment
screen Channel 1 Channel 2
channels
815 5’’ 1 CP, CS35, CS60 -
825 5’’ 2 CS35, CS60, CP, CPEP CS35, CS60, CP, CPEP
CS35, CS60, CS75, CP, CS35, CS60, CS75, CP,

827 7’’ 2
CPEP CPEP

2. Intended use
2.1 Intended users

The patient should not be the operator.
Users (operators) of PhysioMG device can be:

• specialists in the field of the low frequency magnetic field therapy,
• physiotherapists specializing in the therapy of the musculoskeletal system,
• sports medicine specialists,
• aesthetic medicine specialists,
• trained personnel performing treatments under the supervision of the above-mentioned specialists.
The user should have:

• knowledge about the indications and contraindications for the use of electrotherapy, low frequency
magnetic field therapy and laser therapy,
• knowledge of the terminology and technical terms used in the manual (e.g. knowledge of units of physical
quantities),
• practical skills in performing therapeutic treatments using multifunctional devices for therapy, resulting
from education, experience and training.
Physical and cognitive requirements of the operator:

• eyesight enabling to recognize elements of LCD and keyboard,
• hearing enabling to hear the patient's voice,
• reading comprehension that allows to read the instructions of use and information on the LCD of
the device,
• two functional upper limbs that allow to perform treatments and other activities related to the operation
of the device (e.g. cleaning of applicators),
• age in the range of admissible value of professional activity (depending on the regulations of the country
where the device is used).
2.2 User training

The PhysioMG user has to be properly trained in the device safe and effective use, before starting the
operation. Training in the rules of operation can be carried out by representatives of the manufacturer or
seller, based on this user manual. Recommended training positions:
• information about the intended use of the device,
• occupational safety information,
• information on the construction and method of the output signals generation,
• information on available settings and operation modes,
• instructions for use,
• indications and contraindications for the therapy,
• information on recommended maintenance, cleaning and disinfection,
• handling in the event of a technical malfunction.
Due to requirements of local law and regulations in different countries, additional training activities may be
required. The user should inform the seller about such requirements in order to receive complete information.

4.Operational safety
3. Warranty and manufacturer's responsibility

The manufacturer warrants the controller, applicators, couch and trolley to be free of faults for the period of
time and conditions stated in Warranty Certificates. The manufacturer also provides post-warranty service for a
period of 10 years from launching the unit onto the market. Warranty includes all material and workmanship
faults.
The manufacturer undertakes to observe the warranty agreement, if the following conditions are met:
• all repairs, changes, extensions and calibrations of equipment are performed by manufacturer or
authorized service personnel,
• the mains supply system in the treatment room meets requirements of standards in force,
• the unit is operated by qualified personnel, in compliance with instructions presented in this manual,
• the unit is operated in compliance with its intended use.
The warranty does not cover consumables, i.e. connecting cables, mains cables, holders and fuses, straps and
covers, as well as faults or damage caused by:
• improper placement, installation or configuration of the device,
• misuse or failure to observe the instructions presented in this user manual,
• inaccurate or inadequate maintenance carried out by the operator,
• improper environmental conditions specified for the product,
• unauthorized opening of the equipment enclosures,
• adjustment and/or unauthorized calibration,
• use of non-original accessories.
The warranty does not cover any damage due to a failure to adhere to the recommendations stated in
Chapters 4.3 and 10 hereof.
The manufacturer is not liable in case of transmission of infection by equipment components.
The expected "life time" of the device is 10 years.
After elapse of 10 years from date of introduction of device and accessories in the market the manufacturer is
not liable for device and accessories' faults or its consequences. After elapse of the expected life time of
the device the user bears the complete responsibility for the occurrence of medical incidents.
The manufacturer bears no responsibility for results of faulty installation, wrong diagnosis, wrong use of the
device and equipment, failure to observe user's manual and performance of repairs by unauthorized persons.
Inside the device there are no user serviceable components, except for fuses.
No parts can be serviced or maintained when the device is in use with a patient.
On demand, the manufacturer makes available technical diagrams, parts lists, descriptions, instructions
for calibration or other helpful information to appropriately qualified user's technical staff to repair these parts
of unit, which are described by the producer as a reparable.

4. Operational safety
4.1 Mains supply and operation mode

The PhysioMG unit is designed for supply from AC mains with rating 230V ± 10%, 50/60Hz. It is a
medical device under safety class I, type BF. The unit may be used only in rooms, where the electric system is
executed in compliance with standards in force. The unit is intended for continuous operation. It is not
necessary to switch it off from the mains between particular treatment procedures.
The unit is connected to the mains by means of a detachable mains cable. The unit must not be placed in a
way that makes it difficult to disconnect it. The power supply cord is equipped with a mains plug that isolates
the device from the supply mains on all poles simultaneously.
Recommendations related to isolation the device from the supply mains:

• Do not position the device so that it is difficult to operate the disconnection of the device from the
supply mains.
• To isolate the device from the supply mains, hold the mains socket-outlet with one hand, grasp
the mains plug with second hand and disconnect it from the mains socket-outlet.
Disconnection from the mains takes place after:

• removing the mains cable plug from the mains power socket,
• removing the mains cable plug from the socket on the unit,
• switching the mains switch to the "0" position.
4.2 Storage, operation and transport conditions

The unit must be stored in closed rooms, where the atmosphere is free from vapors and caustic substances
and:
• the temperature is maintained between +5°C and +45°C,
• relative humidity does not exceed 75%,
• atmospheric pressure value is between 700 and 1060 hPa (70-106 kPa).
The unit is intended for operation under the following conditions:

• ambient temperature between +15°C and +30°C,
• relative humidity between 30% to 75%,
• atmospheric pressure between 700 to 1060 hPa (70-106 kPa).
If further transport of the device is required, use the delivery packaging. Transport shall be performed with
covered transport means.
Recommended transport conditions:
• ambient temperature between -10°C and +45°C,
• humidity between 20 and 95%,
• atmospheric pressure between 700 and 1060 hPa (70-106 kPa).
4.3 WARNINGS and safety notes

The PhysioMG unit has been designed and manufactured in such a way that its use does not cause a
hazard to the health and safety of patients, operators and third parties, as well as the unit provides
therapeutic benefits to patients if it is operated in appropriate conditions and in accordance with its
intended purpose.
General information:
• The unit may be operated by qualified personnel in compliance with instructions presented
further in this manual.
• To avoid the risk of electric shock, the equipment must only be connected to mains supply with
protective earth (mains socket with grounding pin).
• No modification of this equipment is allowed!
• The treatment station (bed, couch, chair) shall be located away from other electric devices and water
supply / sewerage installation / central heating system, so that it is impossible for the patient to touch
any of them during treatment procedure.
• Do not position the device so that it is difficult to operate the disconnection of the device from the
supply mains.
• Do not remove warning signs and labels put by the manufacturer on the unit casing and casings of
accessories.
• The unit and magnetic field applicators shall be protected against high temperatures and atmospheric
conditions (e.g. direct sunlight).
• Damaged cables and/or applicators shall be replaced immediately. Pay special attention to the casing
cracks, threadbare insulation and partially torn interconnecting cables.
• Prevent any fluid from penetrating inside the unit and applicators. In case of any fluid getting inside the
unit, switch the unit immediately off, isolate from the mains and contact service to inspect the unit.
• By any means do not cover the vents. Do not insert any objects into the ventilation holes.
• The unit may be only used with accessories, spare parts, disposable items which have been determined
to be safe and appropriate inspection bodies have not issued contraindications against their use.
• The couch is designed for stationary work. It is recommended to prepare the couch location so that the
patient can easily access it from at least one side.
• The couch was designed for patients weighing up to 135 kg.
• Changing the position of the couch should not be performed during the therapy.
• Moving the couch with the patient lying on it is prohibited.
• Only one solenoid applicator may be placed on the couch.
• The position of the CP type applicator mounted on a stand or solenoid one mounted on the couch
can only be changed by the personnel operating the unit.
• It is necessary to be careful during carrying the solenoid applicators due to their weight.
• CPEP applicators are not identical to CPE applicators in previous magnetotherapy devices (PhysioGo,
Etius). They cannot be used interchangeably.
• After switching the unit off, wait for 10 seconds before you switch it on again.
• Each serious incident concerned with the device should be reported to the manufacturer
and competent authority of the country, where the user or patient resides. Serious incident means
any incident that directly or indirectly lead, might have led or might lead to any of the following:
 the death of a patient, user or other person,
 the temporary or permanent serious deterioration of a patient's, user's or other person's state of
health,
 a serious public health threat.
Electromagnetic compatibility:
• It is recommended to use original accessories, spare parts and equipment of the manufacturer. Use of
accessories, transducers and cables other than those specified or provided by the manufacturer of
this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
• Use of the PhysioMG adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, the unit and the other equipment should be
observed to verify that they are operating normally.
• Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the PhysioMG, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.

Occupational Health and Safety – magnetotherapy:

• During the treatment carried out near the head, the patient should wear protective glasses (they are
part of the equipment). The solenoid applicators and CP type plate applicator are equipped with
electroluminescent light indicators signaling the generation of magnetic field.
• It is recommended to keep minimal distance 1m between two optional applicators except the dual
mode.
• During the treatment of magnetotherapy the personnel operating the unit and the bystanders
should not be at the distance less than:
 1 m from any plate magnetic field applicator,
 2 m in the axis of the solenoid applicator (along the couch),
 1 m on the side of the solenoid applicator.
• A long-lasting exposure of personnel and bystanders on magnetic field could cause irritation,
concentration impaired, headache and/or insomnia.
• Before the treatment the patient should take off metal elements of clothing and a watch and remove
metal objects from their pocket. The appropriate prohibition label is placed on the applicator housing.
• In the treatment room with unit for magnetic therapy it is necessary to designate and mark magnetic
field exposure zones in accordance with national regulations.
Therapeutic:
• The device is intended for adult patients only. Minor patients – only on the doctor's
explicit recommendation, after considering contraindications
• Treatments for patients:
 having implanted electronic devices (e.g. a pacemaker),
 metal implants,
 with lesions in the initial EEG test,
 who have experienced epileptic seizures,
 who have undergone neurosurgical operations
should be consulted with the attending physician. In such cases, an individual approach and precise
monitoring of the course of therapy in these individuals is recommended. The attending
physician should assess whether the benefits of using magnetotherapy outweigh the risks resulting
from the above-mentioned factors.
• Before performing the treatment, make sure there are no contraindications to its implementation.
• If the therapy is carried out on ulcerations, decubitus ulcers, burns in the phase with effusion or
post-traumatic wounds in the inflammatory phase, the treated area should be protected with a
sterile dressing, e.g. gauze.
• Act with caution in severe vascular diseases (obliterative arteritis of the lower limbs, diabetic
angiopathy, severe angina pectoris).
• Treatment parameters and the arrangement of the applicators should be consistent with the medical
indications.
• Sitting or reclining position should be applied to the patients with respiratory disorders or
breathing difficulties.
• In case of treatment, when the patient is lying on the couch, his/her head should be directed towards
the headrest or should be resting on it, legs should be directed towards the shelf of the unit.
• The operator should supervise the moment when the patient lies down on the couch and gets up from
it, so that he does not hit or catch on the shelf for the unit and the unit itself.
• It is not recommended to treat pregnant women with magnetotherapy.
• Do not perform treatments on patients under the influence of alcohol.
• Do not perform treatments on patients under the influence of intoxicants.
• Due to the possibility of occurrence of sleep disorders, avoid, if possible, magnetotherapy
treatments carried out in the evening. This applies mainly to the elderly people.
• It is necessary to inform the patient about the sensation of heat – applicators may become hot during
operation (see section 4.4).
• During therapy by means of low-frequency magnetic field the patient should not undergo X-
ray examinations and ionizing radiation.
Also read the information given in chapter 9.3.

4.4 Applied parts and working temperature

Magnetic field applicators in general do not require, for the accomplishment of therapeutic function, any
contact with the patient's body. Therefore, they are not directly subject to the definition of an applied part
that complies with the basic safety standard for medical products (in Poland PN-EN 60601-1, in Europe EN
60601-1, both based on IEC 60601-1).
For CP and CPEP plate applicators, for which the patient's body is in contact during the treatments,
the requirements related to acceptable temperatures are met, as for the applied parts. At the point of contact,
the temperature of 41°C is not exceeded.
The solenoid applicators heat up to higher temperatures than the plate applicators due to their design,
principle of operation and expected induction values. Maximum temperatures of solenoid applicators:
• external surface – made of metal – 54°C,
• internal surface – molded material – 62°C.
Limit values according to the standard given in the first paragraph, according to table 23, second row - contact
time 1 – 10 s:
• metals and liquids – the external surface of the applicator – 56°C,
• molded materials, plastic – Internal side of the applicator housing – 71°C.
In case of the solenoid applicators, contact between the housing and the patient's body is rare and the
contact is usually accidental. Temperatures on the surface of the solenoid applicators do not pose threat to
the patient or the operator. The surface temperature of the couch and the pillow in the CS35 applicator do
not exceed 41°C.
The expected benefits of using magnetotherapy outweigh the risks associated with the surface temperatures of
the solenoid applicators.
A label informing about temperatures is placed on the housings of the solenoid applicators.
Figure 4.1. A label informing about the temperatures of the solenoid applicators
4.5 Explosion proof environment

The unit is not adopted to operation in rooms, where combustible gases or their vapors occur. It is
recommended to avoid anesthetic or oxygen derivate gases, such as nitrous oxide (N 2 O) and oxygen. Some
materials, e.g. cotton, after oxygen saturation can be burned at high temperatures generated during normal
use of the device. It is recommended that solutions of adhesive and combustible solvents be vaporized
before equipment is operated. It is also recommended to pay attention to the danger of ignition of
endogenous gases. The unit must be separated from the mains before approaching the disinfection room,
where it is installed.
4.6 Electromagnetic environment

Warnings concerning electromagnetic compatibility are given in the chapter 4.3. The expected places of
operation of the unit are given in Chapter 2.
Due to the intended use, the unit can be used in hospitals, clinics, outpatient clinics, doctors' and rehabilitation
offices and other health care institutions, under the supervision of qualified personnel.
Simultaneous operation of the unit with devices generating strong electromagnetic field, such as short wave
and microwave diathermies, high frequency surgical equipment, MRI systems, may disturb the unit operation.
For this reason, it is recommended to maintain appropriate distance between these devices or to switch off the
generator of strong fields during therapy with the PhysioMG unit.
The PhysioMG meets requirements of electromagnetic interference emission and immunity standards and
shall not pose a threat to correct operation of the other devices. Compliance levels for emissions and
immunity are given in the chapter 11.2.
Magnetic field applicators are marked with non-ionizing radiation symbol, because they emit electromagnetic
field energy for healing purposes.
4.7 Operation of touch-sensitive displays

Table 2. Recommendations for the operation of touch screens
Model Type of display Method of operation of the display
Recommended:
815 • Pen designed for resistive screens – preferably with
5” with a resistive touch- a narrow plastic tip
sensitive panel Admissible:
825 • Operator's finger – much lower comfort of operation
compared to the pen
Recommended:
7” with a capacitive touch- • Operator's finger
827
sensitive panel • Pen designed for capacitive screens – preferably
with a rubber tip
4.8 Technical supervision

The User of PhysioMG unit must perform technical inspection of the unit at year intervals. The inspection
should be performed by a unit authorized by the manufacturer. The inspection is performed at the
user's expense.
The inspection should include:
• safety test – measurements of leakage currents and grounding continuity,
• control of correctness of the performed self-test,
• measurements of the magnetic field induction emitted by the applicators,
• evaluation of touchscreen function and operation,
• evaluation of keyboard function and operation,
• verification of the magnetic field applicators condition for casing defects and damage of interconnecting
cables and connectors,
• examination of the mechanical structure of the stand, couch and trolley in terms of stability, technical
condition, quality of connections and integrity, in particular checking:
 the condition of the brakes in the stand and trolley wheels – whether they are broken or cracked,
 whether the fastening screws are not loose,
 condition of the gas spring (actuator),
 condition of the stand height adjustment lever,
 condition of the pushbutton and the lever for adjusting the position of the stand bar.
The inspection must also include verification of the quality of applied accessories and treatment materials. The
inspection should be documented by a test report.
Positive result of the technical inspection confirms that basic safety and essential performance is maintained.

4.9 Disposal
In case, when the disposal of the unit will become necessary (e.g. after elapse of its service life), please
contact the manufacturer or manufacturer representative, which must react in an appropriate way i.e.
collecting the unit from the user. The user may also contact companies specialized in removal and/or
disposal of electrical devices or computer equipment.
The unit is marked with an appropriate symbol complying with the directive on waste electrical and electronic
equipment (WEEE) – see table with description of the symbols used to label the product presented
in Appendix A.

5. Unit description
5. Unit description
5.1 General characteristics

Low frequency magnetic field therapy unit PhysioMG is a highly specialized medical device based on modern
microprocessor platform.
The unit has a plastic console casing. PhysioMG 827 (Figure 5.1) is equipped with a 17.8 cm (7 ") color
touch liquid-crystal display, and PhysioMG 825 and 815 (Figure 5.2) with a 12.7 cm (5")
display. The mains switch, fuse socket and mains socket are located on the rear side of the casing.
Output sockets for connection of accessories are located on the rear panel. The unit has the possibility of
changing its angle of inclination. For this purpose, feet in the rear side of the casing have been developed.
They can be folded or unfolded.
Figure 5.1 General view of the PhysioMG 827
Figure 5.2. General view of PhysioMG 825 and 815 units

5. Unit description
5.2 Keyboard
Arrangement of keyboard components is shown in figure 5.3.
Figure 5.3 Arrangement of keyboard components on the example of PhysioMG 827

Arrangement of keyboard components”
Symbol Description Function
The indicator determines the readiness for operation:
• it is off – the power switch is turned off,
• it blinks – the power switch is on and the power cord
1 Indicator
is connected, but the device is not running,
• is on continuously – the device is running.
Battery indicator visible in model 827 is not used.
Its pressing causes abolition of action and going over on an early
menu level.
2 Escape key
Pressing of this key during treatment procedure results in
immediate interruption of the procedure.
Turn ON/OFF key The button is used to start and turn the unit off in a proper
3 manner (see section 7.12).
(STANDBY)
It is used to confirm:
• selection of applicator in a particular treatment channel,
• function in program mode,
4 Confirmation key
• saving of user-defined program,
• functions in setup mode,
• changes in the unit settings.
They are used for:
5 Edit keys • switching between parameters (left / right)
• increasing / decreasing of parameter values (up / down)
Pressing START key results in generation after:
• selection of a treatment program, favorite program or user-
defined program/sequence in program mode,
6 START key • ending of parameters edition in manual mode.
Pressing START key after interruption of a treatment procedure
using STOP key (pause) makes it possible to continue the
procedure.
Pressing STOP key while performing treatment procedure results
7 STOP key in treatment interruption and automatically the unit enters the
standby mode (pause). The treatment timer will stop.
8 LCD screen Touch screen 5’’ or 7’’ depending on the device model.

5. Unit description
5.3 Magnetic field applicators

The following types of solenoid applicators can be used with Physio MG (depending on a model, see 6.1.1)
(Figure 5.4):
• CS35 – solenoid applicator with a diameter of 35 cm,
• CS60 – solenoid applicator with a diameter of 60 cm,
• CS75 – solenoid applicator with a diameter of 75 cm.
Figure 5.4 CS35, CS60 and CS75 solenoid applicators

In all solenoid applicators (alternatively referred to as solenoids), a treatment field illuminator
(electroluminescent source with low light intensity) was installed, placed in the upper part of the
housing. Lighting indicates the ongoing emission of the magnetic field – in the intermittent mode the light will
flash.
The CS60 and CS75 type applicators are designed for mounting on the LE_CS type couch.
Figure 5.5 View of the controller and solenoid applicator with a couch
The CS35 applicator is equipped with a pillow, on which the patient can support his arm or leg during therapy.
This applicator can be placed on a ST_CS type trolley (Figure 5.6) equipped with wheels and with brakes.
5. Unit description
Figure 5.6. CS35 applicator on the trolley

Supported types of plate applicators (depending on a model, see 6.1.1):
• CP – applicator consisting of two interconnected parts, it is designed for mounting on a stand, both parts
are equipped with electroluminescent diodes illuminating the treatment field (Figure 5.7).
• CPEP – applicator consisting of two interconnected parts, designed to be fastened by means of Velcro
belts (Figure 5.8).
NOTE: CPEP applicators are not identical to CPE applicators in previous magnetotherapy devices (PhysioGo,
Etius). They cannot be used interchangeably.
The design of the stand for CP applicators enables height adjustment (owing to the use of a gas spring) and the
angle of rotation and deflection of the applicator. The stand is equipped with four castors, each with a brake.
The LED indicators used in the magnetic field applicators are orange.
Figure 5.7. CP applicators on a stand

5. Unit description
Figure 5.8. CPEP applicators

Detailed information on the parameters of the unit and applicators is given in chapters 8 and 11.
5.4 Name plates

The name plate is located on the side of unit casing. Among others there are following data placed
on the name plate (see Appendix A):
• device version,
• serial number,
• nominal voltage and operation frequency,
• maximum power consumption,
• type of applied fuses,
• manufacturer’s data.
Nameplates are also placed on magnetic field applicators and other accessories (couch, trolley).

6. Device installation and start-up
6.1 Installation
The first installation should be performed by a qualified manufacturer's or distributor's representative!
After removing the elements of the ordered set from the transportation packaging, depending on the
conditions during transport, it is recommended to wait up to two hours before further installation
operations begin. This is aimed at adaptation of the unit to conditions in operation room.
First check, if the complete equipment of the kit elements has been delivered. In the event of
any incompatibilities contact your distributor or the manufacturer. The unit shall be placed (e.g., mounted on
the shelf of the couch or the stand of CP applicator near mains socket with power input 230V ± 10% and
50/60 Hz. Due to manufacturing under safety class I the unit can be connected only to a socket with protective
earth pin. It is recommended to place the unit at such a height that it would enable convenient operation
from the front panel. The light shall enable easy readout of display indicators, however the unit shall not be
exposed to direct sunlight.
Instructions for the assembly of the LE_CS type couch, the ST_CS type trolley for applicators and the stand of
CP applicator are provided in the form of separate documents. You will find them in the packaging of the
listed products. Before making connections, the structure elements should be properly assembled.
6.1.1 Connection of magnetic field applicators
Connect the applicators when the controller power supply is turned off.
Depending on the model of the unit, connect the applicator to the appropriate socket. In order to facilitate the
connections, the socket label contains indications which sockets the applicators can be connected to.
Figure 6.1 View of the PhysioMG 827 sockets label

Sockets label:
Symbol Description
1 Applicators sockets
2 Admissible configuration of applicators in a given model
3 Power switch
4 Fuse socket
5 Power socket


Table 3. Permissible configurations of applicators in the sockets of various models of PhysioMG
Model Designation of a socket The type of applicator used
815 A1 CP CS35 CS60
A1 CS35 CS60 -
A2 CS35 CPEP CP
825
B1 CS35 CS60 -
B2 CS35 CPEP CP
A1 CS35 CS60 CS75

A2 CS35 CPEP CP
827
B1 CS35 CS60 CS75
B2 CS35 CPEP CP
If the applicator is not connected conforming to the recommendations, a message will appear on the display
with the code and description of the error. (Figure 6.4).

Figure 6.4. Incorrectly connected applicator
6.1.2 First operation
Connect the unit to mains supply with delivered detachable mains cable. Turn the unit on. After switching the
mains supply on proper work of all blocks are tested.
If after switching on mains supply the display is illegible, check whether mains fuse or mains cable operate
correctly. Care shall be given to apply fuses with rating given on the name plate. If fuse and cables are
working properly, contact the service.
If the self-test results in appearing on the display the information about unit or connected applicator defect
along with the error code, turn the unit off and contact with a service representative.
6.2 Setup mode
6.2.1 Basic information
Keyboard components designed for the unit operation are called ”keys”.
The area on the screen, where after its pressing a specific unit reaction is followed, is called ”button”.
The area on the screen that has the possibility to select or deselect any item, is called ”selection field”.
To enter Setup mode, press
To leave Setup mode, press
To go back one level, press
6.2.2 Language
With the unit information on the display may be presented in different language versions (depending on the
software version). The user is free to select language options.
To set the language version, press the Language button in the list of setup options, then press the desired
version. Language version change is immediate.

6.2.3 Global settings
6.2.3.1 Date and time

In this section there is a possibility to adjust date and time. To change these settings, press the button Edit.
Using arrows, set the required value. Confirm settings using Set button or leave the edition mode by
pressing Cancel.
Figure 6.5 Screen view – date and time edition
6.2.3.2 Sounds
The user may configure settings of acoustic signals, which occur during unit operation. Description of available
configuration options:
• Keys sound
• Sound during treatment
• End of treatment sound
• Warning sounds
• Initial sound
• Repeatable sound of the end of treatment – if the option is selected, the sound will be played until the
moment when an operator reacts, with the option unchecked, the sound will be active for 30 seconds.
In order to set the appropriate option, select or clear the selection field by its pressing.
6.2.3.3 Volume
The user may adjust sound volume level. To perform this action:
• press the volume bar at desired place, or
• use buttons on the screen.
6.2.3.4 Display
The user may adjust display brightness level. To perform this action:
• press the value bar at desired place, or
• use buttons on the screen
6.2.4 Functional settings
6.2.4.1 Channel operation mode selection

This function allows the user to set preferred style of unit operation.
Option Explanation
After therapy selection, the unit is set in manual mode of the

Manual mode – automatically
operation.

Option Explanation
After therapy selection, the unit is set in program mode of the

Program mode – automatically
operation.
After therapy selection, the unit displays a window with a list of
Mode selection pop-up
operation mode selection options.
6.2.4.2 Program groups / medical fields

This function allows the user to set filters of available program mode options according to the preferred
program groups or medical fields. In order to set the appropriate option, select or clear the selection field by
its pressing.
For program groups, the following options are available:

• Preset programs
• User programs
• User sequences
For medical fields, instead of the preset treatment programs the following options classified by medical
nomenclature are available:
• Orthopedics
• Sports medicine
• Aesthetic medicine
• Rheumatology
• Neurology
• Urology
• Dermatology
• Angiology
• Gynecology
• Stomatology
The classification of preset treatment programs into the above-mentioned categories do not limit their
applications in other fields, according to the knowledge and experience of doctors and physiotherapists.
6.2.4.3 Induction units

This function allows the user to select magnetic induction units – Gauss [Gs] or militesla [mT] (1mT = 10 Gs). In
order to set the appropriate option, select or clear the selection field by its pressing.
6.2.4.4 Induction representation

The function allows you to change the method of presentation of the amplitude of magnetic field induction
from among:
• peak-to-peak value,
• reference value,
• maximum value.
6.2.5 Service
6.2.5.1 Miscellaneous
The function by the Delete user programs button allows you to remove user-defined programs.
Selecting or unselecting the Test the touch panel check box allows to check the touch screen operation – on
the touched spots an indicator occurs.

In models 815 and 825, selecting the Test the touch panel button starts the display calibration procedure.
Follow the messages on the screen. First, touch three points, then validate the operation by touching five
points on the screen.
6.2.5.2 Date of inspection

There is possibility to enter into the device the date of the next inspection – it will automatically remind you
about the need to perform an annual technical inspection.
6.2.6 Statistics
6.2.6.1 Info
Provides information about the version of the unit, software, interface and software build date.
6.2.6.2 Unit statistics

Provides information about the number of treatment procedures performed. Statistics can be deleted. If you
want to delete statistics, press Delete programs counters button.
6.3 Transport position
6.3.1 Couch
• The couch is designed for stationary operation.

• Changing the position of the couch should not be performed during therapy.
• Moving the couch when the patient is lying on it is prohibited.
• Before changing the position of the couch, dismount the unit from the shelf, remove the CPEP
applicator from the shelf and / or remove other items if they are on the couch.
• Ask other people for help. Make sure that these people will be able to lift the couch. The presence of at
least three people is recommended for moving the couch – two to carry it, the third one to hold the CS
60/75 type applicator mounted on the couch.
• If you have only one person to help, first make sure you can move the couch. Then dismount the applicator
– see "Assembly instructions for the LE_CS couch for its operation with Physio MG". After moving and
arranging the couch, reinstall the applicator.
• After completing the transportation mount the unit on the shelf.
6.3.2 The stand with CP applicator
• Before transport, disconnect from the controller the power cord and all applicators except for the CP
applicator.
• Then unlock the brakes and transport the stand.
• After completion of transport and positioning at the destination place, lock the brakes and reconnect the
cables.
6.3.3 Trolley for applicators
• Remove the applicator from the trolley during transportation.

• Then unlock the brakes and transport the trolley.
• After completing the transport and arranging the unit in the destination place, lock the brakes.

Figure 6.6. Transport position of the trolley

7. Unit operation
7. Unit operation
The unit may operate in one of two modes:
• program mode,
• manual mode.
In the program mode you can use preset procedures of treatment programs, user-defined programs and
sequences. In the program mode you cannot edit the introduced parameters. Such an option is available in
the manual operation mode.
Notes – unit operation:

• In the program mode you can use preset procedures of treatment programs, as well as user-defined
programs and sequences.
• In the program mode you cannot edit the preset programs parameters. However, they can be easily
”copied” to the manual mode. In order to do it, press the button .

• There is a possibility to repeat the completed treatment. In order to do it, press on the keyboard or
screen.
7.1 Patient preparation and treatment performance
7.1.1 General information
To perform safe and effective treatment procedure you are obliged to:
• make sure if there are no contraindications to perform the treatment,
• the patient should be placed in a comfortable position while providing relaxation of tissues in the
treatment area, the patient should be in lying position in case of treatment performed near the head,
• sitting or reclining position should be applied to patients with respiratory disorders or breathing
difficulties,
• inform the patient about feelings that may occur during treatment.
The treatment effectiveness depends on the choice of parameters to the current patient’s condition. The
patient’s condition changes over time. Its observation and assessment should take place before, during and
after therapy. Such an action is necessary for changing the parameters in order to adapt them to the actual
condition of the patient.
It is recommended to keep records of treatments including the parameters of therapy, the area of treatment,
treatment technique, dose and symptoms after therapy. If the treatment does not generate the intended
effects, change of treatment parameters should be taken into consideration. It is necessary to continuously
update knowledge and follow literary activities in the scope of therapy.
When performing therapy, it is recommended to follow the guidelines given in the following sections.
7.1.2 Magnetotherapy
• Prior to treatment it is necessary to check the presence of magnetic field by means of magnet (hand
with magnet inserted within the applicator).
• Other types of therapy carried out at the same time do not constitute a counter-indication to use the
therapy of low-frequency magnetic field.
• Treatments may be carried out through clothes, plaster, bandages.
• It is necessary to inform the patient that during treatment they will not sense anything.
• It is necessary to control the feeling of the patient, especially during treatments in the area of the head.
• It is necessary to properly fix the magnetic field applicator to the body of the patient, e.g. by means of
Velcro belts or flexible bands.

7. Unit operation
• In order to avoid possible exacerbation of conditions the treatments must be started with a small dose,
i.e. first treatment around 40%, second 70%, third 100% of the prescribed dose.
• First 5-15 treatments should be carried out on a daily basis, whereas subsequent treatments 2-3
times per week.
7.2 Screen configuration
Figure 7.1 Field description

Configuration of treatment screen:
Symbol Description Function
1 Status tab Date and time
This field shows:
• available applicators
• treatment parameters in manual mode
2 Edition field
• list of preset treatment programs
• list of user-defined treatment programs and sequences
• settings
Available in two-channel models of the unit – details are
3 Channel selection tabs described in chapter 7.3 .
Therapy selection menu
Program mode
Manual mode
4 Main menu User-defined treatment programs and sequences
edition mode
Information mode
Setup mode
Note: If the edition / main menu field is grayed out, it means that it is inactive.

7. Unit operation
7.3 General configuration
7.3.1 Treatment channel configuration – for two-channel models
Sample configuration of applicators in therapeutic channels, based on the example of PhysioMG 827:
Channel Applicators
Solenoid applicator CS60
1 Plate applicator CPEP
Dual mode
(see 7.5)
Solenoid applicator CS60
Plate applicator CP
The appearance of the screen depends on the types of connected applicators. After selecting the Dual mode
option, it is not possible to carry out the treatment in the second channel.
7.3.2 Channel selection tabs
The channel selection tabs are displayed on the screen – In the two-channel models marked with the numbers
1 and 2, in the single-channel model only one tab is available. They present:
• selected therapy symbol,
• treatment time,
• information related to the particular channel operating status.
The color of the tab is identical to the background color of the edition field. In the background, other operating
tabs are black.
Figure 7.2 Location of channel selection tabs

7. Unit operation
The table below explains the meaning of the symbols presented in tabs:
Symbol Definition
Symbol of low frequency magnetic field therapy
Ongoing treatment
Treatment interrupted
Ready to start amplitude adjustment or pause
Channel error (yellow symbol)
7.4 Display description

The treatment screen is presented after the treatment is started – in manual or program mode. The most
important information about the ongoing therapy is presented.
Figure 7.3. An example of the appearance of a treatment screen for magnetotherapy treatment – a single applicator
Magnetotherapy treatment screen – single applicator:
Symbol Description
1 Applicator identifier / program name.
2 Magnetic induction.
3 Tab field (channel 2).
4 Indication of the treatment elapsing time.

7. Unit operation
Figure 7.4. An example of the appearance of a treatment screen for magnetotherapy treatment – dual mode
Treatment screen of magnetotherapy – dual mode:
Symbol Description
1 Applicators identifiers / program name.
2 Magnetic induction of the plate applicator CPEP.
3 Magnetic induction of the solenoid applicator (herein CS75).
4 Active tab area.
5 Inactive tab field.
6 Indication of the treatment elapsing time – common for both applicators.
7.5 Dual mode

The dual mode is a special way of conducting therapy that allows simultaneous systemic impact by means of
CS60 or CS75 solenoid applicator and locally, using a CPEP plate applicator. It is available in two-channel
models of the unit.
The operating parameters are set separately for each applicator. Switching between applicators is done using
the and buttons, and the applicator icon indicates which parameters are edited. The duration of the
treatment is common – the treatment clock is available on the plate applicator tab.
Figure 7.5. View of the parameters edit screens in dual mode

7. Unit operation
7.6 Application of magnetic field

The illustrations below show examples of magnetic field application.
Applicator Example
CS60 / CS75
CS35
CP
CPEP
Figure 7.6 Examples of magnetic field application

7. Unit operation
7.7 Operation with preset treatment programs

The simplest method of unit operation is to use its preset programs. The unit includes a database containing
several dozens of most frequently met disorders together with suggested treatment types and parameters. In
this mode, the operation is reduced to selection of disease entity from the list. The parameters and information
about the treatment are available in the information mode.
The values of the preset treatment programs parameters are based on the available literature data and they
are determined as average values. Parameters should be treated exclusively as indications. Sole
responsibility for application of preset treatment programs bears the User.
Operation scheme:
Step Description
1. Connect the magnetic field applicator/s.

2. Switch on the power supply with the power switch, turn on the unit by means of the STANDBY key.
3. Select the therapeutic channel 1 or 2 and then the applicator.
4. Press the field Program modes
5. Select the option Preset programs from Program modes menu. Confirm by the key or once
again press the selected field.
6. Select the program from the list.
7. Prepare the patient for the treatment according to indications in point 7.1
8. Press the key .
9. Using the keys optionally adjust the induction value.
Pressing the button after program selection results in appearing information which contains:
• technique description of magnetic field applicators placement,
• illustrations with highlighted points or areas of the body covered by the treatment,
• suggested number of procedures, the frequency of repetition,
• notes,
• treatment parameters.
The induction value presented in the program description is the reference value. See table in chapter 8.1.
Figure 7.7 Samples view of the information screen

7. Unit operation
Information mode navigation:
Symbol Explanation
Approval of the program and return to the list (the current position)
Back to the list of preset programs
Go to the next program
Go to the previous program
Model of the human body – go to the previous / next illustration for the program
Enlarged illustration with an example of application
Use keys or a bar located on the right side of the display to scroll the information.
In order to enlarge the view of the exemplary application of the applicator, press the button. If the program
in the encyclopedia contains more than one illustration, the magnifier will be visible only on the first one.
It allows to open the extended illustration on the entire screen, showing the view from a different
perspective. This option is particularly useful for models with a 5" screen.
To close the enlarged illustration, click the screen anywhere. You can also use the keys:
• – to start the treatment,
• – to return to the list (to the current position),
• – to return to the list of preset programs.
Figure 7.1 Sample view of the enlarged illustration
If it is necessary to interrupt the treatment procedure (pause), press key. To resume the treatment
procedure, it is recommended to follow the instructions shown on the display.

7. Unit operation
7.8 Favorite programs

The function offers quick access to frequently used preset programs without browsing the entire list.
To add or remove the program from the favorite list, follow the instructions:
Step Description
1. Prepare the unit to work with preset treatment programs (see steps 1-5 described in section 7.6).
2. Select program.
add remove
Press the symbol next to the name of the

3. Press the symbol next to the name of the
program. Symbol color changes to yellow and
program. Symbol color changes to blue and the
the program is inserted on the favorite list.
program is deleted from the favorite list.
You can also delete programs from the list of

4. ---
favorites by following the steps above.
To enter the favorite list, press the symbol .
If no item from the preset treatment program or sequences list is selected as a ”favorite”, then after entering
the option, the list will be empty.
NOTE:
Favorite option is not available when you set the view of preset treatment programs by medical fields. See
point 6.2.4.2.
7.9 Manual mode operation

Symbol definition and parameters range are given in chapter 8.
Step Description

2. Switch on the power supply with the power switch, turn on the unit by means of the STANDBY key.
4. Press the field Manual mode

By means of the keys or by clicking the symbol, select the parameter to be edited, by using
5.
the keys set its value.
6. Prepare the patient for the treatment according to indications in point 7.1
7. Press the key .
8. If it is necessary, during treatment procedure, using the keys set the amplitude.
If it is necessary to interrupt the treatment procedure (pause), press the key . To resume the treatment
7.10 User programs

The User has the possibility to save in to the device memory own sets of treatment parameters in the form of
programs.
7. Unit operation
Saving of user program:
Step Description
1. Prepare the unit to work in manual mode (steps 1 – 5 see section 7.9).
2. Set the program parameters.
3. Press the button from main menu.

4. Select the item number under which the program will be saved. Confirm your choice with the key .
5. Enter the program name. Press the key or button
The user-defined programs are selected in the same way as preset treatment programs. In Program modes
menu select the option User programs.
Edition of user program:
Step Description
1. Prepare the unit to work in the program mode (see section 7.6).
2. Select the option User programs from Program modes menu. Confirm by the key or once again
press the selected field.
3. Select the program for edition.
5. Select the action – Edit.
6. Correct the parameters.
8. Select the item number under which the program will be saved. Confirm your choice with the key
9. Enter or edit the program name. Press the key or button
Removal of user program:
Step Description
3. Select the program which will be deleted.
5. Select the action – Remove.
6. Confirm by pressing the key or button or resign using the key or button .
User program parameter view:
Step Description
3. Select the program which parameters will be checked.
4. Press button
5. Press the key or button to return to the user-defined treatment program list.
7. Unit operation
7.11 User sequences

The unit is equipped with an advanced editor which allows you to create magnetotherapy treatment sequences
(excluding the dual mode). A single sequence may consist of up to four stages. The sequence may be created
from previously saved user-defined programs.
The user sequences are selected in the same way as preset treatment programs. In Program modes menu
select the option User sequences.
Step Description

2. Switch on the power supply, turn on the unit.
4. Press the field Program modes
5. Select the option User sequences from Program modes menu. Confirm by the button or once
6. Select the sequence from the list.
7. Prepare the patient for the treatment according to indications in point 7.1.
8.
Press the key
9. If it is necessary, during treatment procedure, using the keys set the amplitude.
If it is necessary to interrupt the treatment procedure (pause), press the key . To resume the treatment
Creation of user sequence:
Step Description
Press the button from main menu.

3. This opens the user’s sequence editor.
Select the item to be saved. Press
From the list of user programs, select the

program and press
4. Repeat the action for additional items. The
sequence may consist of up to 4 programs,
it has to contain minimum two programs.
5. Use the sequence edition tools described below to make changes in the created sequence.
6. Press the button to save the sequence. Enter the name. Then press
7. Press the button to escape from the sequence editor.
7. Unit operation
User sequence edition:
Step Description
3. Press the button from main menu. This opens the user’s sequence editor.
4. Select the sequence. Press
5. Use the tools described below.
6. Press the button to save the sequence. Enter or modified the name. Then press
Sequence edition tools:
Button Explanation
1. Select the user-defined program – left side of the edition screen.
2. Press , selected item will be added as a new step of the sequence.

1. Select the sequence step – right side of the edition screen.
2. Press . Step will be deleted.

2. Press . Step will be moved up one level.

2. Press . Step will be moved down one level.
Removal of user sequences:
Step Description
2. Select the option User sequences from Program modes menu. Confirm by the button or once again
4. Select the sequence. Press
5. Confirm by pressing or resign using

7. Unit operation
7.12 Safe shutdown procedure

The work flow for the safe termination of the operation:
Step Description
1. Proceed with the treatment to the end or stop it by pressing the key.
2. In case of treatment carried out by using a CPEP type applicator, remove it from the patient.
3. Click the UNIT ON / OFF (STANDBY) button on the front panel .
After clicking the button, a message will appear on the display as it is shown on the screen below.
4.
If you want to confirm the operation, select the button, pressing of which will switch the unit off
5.
properly. If you quit turning the unit off, select .
After closing the system, you can disconnect the unit from the power supply network by means of
6.
power switch.
7. If you do not use the device for a long time, remove the mains cable plug from the mains socket.
8. Definitions and parameters
8.1 General information

Characteristics of magnetic induction sources:
Maximum Induction at the
Magnetic field
Symbol / Applicator type induction reference point Operation mode
shape
[mT] [mT]
CS35 Any 0,5-12 0,5-10 continuous / intermittent
continuous / intermittent
CS60 Any 0,5-6 0,5-4
CS75 Any 0,5-4,5 0,5-3,0
Pulse 0,5-50 0,5-25
CPEP
Other 0,5-20 0,5-10
Pulse 0,5-12,5 0,5-3
CP
Other 0,5-10 0,5-2,5
Pulse 0-56
Dual mode -
Other 0-26
The peak-to-peak value is given in relation to the maximum induction.
8.2 Treatment parameters

Characteristic of treatment parameters:
Symbol Definition Available parameters
Solenoid CS35
Solenoid CS60
Type of applicator Solenoid CS75
Plate CP
Plate CPEP
Shape of magnetic field Double-half rectangular

Symbol Definition Available parameters

Double-half triangular
Double-half sinusoidal
Double-half pulse
Single-half rectangular
Single-half triangular
Single-half sinusoidal
Single-half pulse
2 Hz – 120 Hz with variable step (manual
Solenoid adjustment possible by "holding" with
applicators the pen / finger of the frequency field – in
Magnetic field increments of every 0.01 Hz, Figure 8.1)
frequency 2 Hz – 140 Hz with variable step (manual
setting possible by "holding" with the
Plate applicators
pen / finger of the frequency field – in
increments of every 0.01 Hz, Figure 8.1)
Spectrum of frequency
0; 5; 10; 20; 50 Hz
change (deviation)
Pause time in the • cont – continuous mode
intermittent mode • pause time – settings 0,5; 1; 1,5; 2; 3; 4; 6; 8 s
Pulse time in the
Continuous, 1 s
intermittent mode
The maximum induction value is presented:
• solenoid applicators – the maximum induction value
measured at the inner wall of the applicator surface in its
half
Induction
• CP applicator – the maximum induction value measured
at the inner wall of the applicator surface in its center
• CPEP – the maximum induction value measured at the
center of the applicators system folded together
Induction The presented peak-to-peak value of the maximum induction.
The value at the reference point is presented:

• solenoid applicators – the geometrical center of the
applicator is taken as the reference point
• CP applicator – the geometrical center of the applicator
Induction system with the internal side facing each other is taken as
the reference point
• CPEP applicator – the reference point is the center of the
inner surface of any of the applicator elements, where the
second element is located next to it
30 s – 60 min with step every 30 s (manual adjustment is
Treatment time possible by "holding" the field with time by means of a pen /
finger – in increments of 1 s, Figure 8.2)

Figure 8.1. Manual frequency setting
Figure 8.2. Manual time setting
8.2.1 The mode of magnetic field generation
PhysioMG has two modes of magnetic field generation: continuous and intermittent.
In continuous mode, the magnetic field is generated with a constant amplitude throughout the duration of the
treatment. This mode is selected by setting the cont value in the “Pause time in the intermittent mode”
parameter.
In the intermittent mode, the magnetic field is generated for 1 s (T imp ), followed by a pause (T pause ).The length
of the gap can be set within the range from 0.5 s to 8 s. Figure 8.3 and Figure 8.4 show the principle of
operation in the intermittent mode.
Figure 8.3. Single-half wave

Figure 8.4. Double-half wave
8.2.2 Spectrum
The spectrum determines the frequency modulation range as a function of time. The frequency is modified
symmetrically with respect to the basic frequency (Figure 8.5).
Figure 8.5. Frequency spectrum
Examples for solenoid applicators:

Base frequency fg Minimum frequency Maximum frequency
Spectrum [Hz] Remarks
[Hz] fg min [Hz] fg max [Hz]
Limitation of induction
2 10 2 7 in the lower range
(min 2 Hz)
50 20 40 60 -
Limitation of induction
100 50 75 120 in the upper range
(max 120 Hz)
Warning: The frequency deviation period is fixed at 10 seconds and it is permanent (5 seconds increase and 5
seconds decrease in frequency). The course of changes is linear, and the frequency change pace is 10 ms
(100x within a second).

8.3 Limitation of induction with frequency increase

Due to the limited current slope rise rate in the coils of the solenoid applicators, there occurs a phenomenon of
limiting the induction generated in applicators with the increase in frequency. The higher the frequency, the
lower the induction. The characteristics of induction changes measured at the reference point (geometric
center of the applicator) as a function of frequency are presented below.
Legend:

Figure 8.6. Decrease in induction value with frequency increase

The unit also features a mechanism to limit the induction when two applicators are operated simultaneously in
two-channel controllers. The purpose of the protection is to limit the possibility of exceeding the rated
parameters of the components affecting the safety of the unit.

9. Indications and contraindications
9.1 Indications
• delayed union of fractured bone
• pseudarthrosis
• osteoporosis
• degenerative joint disease
• rheumatoid arthritis
• ulcerations and trophic shank changes
• bacterial infection of skin and soft tissues
• keloids
• condition after cerebral stroke
• hemicrania and vasomotor headaches
• functional disorders of cranial and peripheral nerves
• multiple sclerosis
• cornea infection diseases
• optic atrophy
• arterial hypertension
• ischemic heart disease
• heart arrhythmia
• hypersensitive large intestine
• chronic pancreatitis
9.2 Contraindications
• pregnancy
• neoplastic disease
• active tuberculosis
• juvenile diabetes
• thyrotoxicosis
• bleeding from alimentary system
• severe infections
• presence of electronic implants (e.g. cardiac pacemaker)
Treatments for patients:

• having implanted electronic devices (e.g. a pacemaker),
• metal implants,
• with lesions in the initial EEG test,
• who have experienced epileptic seizures,
• who have undergone neurosurgical operations
should be consulted with the attending physician. In such cases, an individual approach and precise
monitoring of the course of therapy in these individuals is recommended. The attending physician should
assess whether the benefits of using magnetotherapy outweigh the risks resulting from the
above-mentioned factors.
If the therapy is carried out on ulcerations, decubitus ulcers, burns in the phase with effusion or post-
traumatic wounds in the inflammatory phase, the treated area should be protected with a sterile dressing,
e.g. gauze.

9.3 Possible side effects

• tingling or numbness in the body parts undergoing treatment
• feeling of heat in the location of therapy
• general irritability
• insomnia
• concentration disorders

10. Maintenance, cleaning, disinfection

NOTE: The warranty does not cover any damage due to a failure to adhere to the recommendations stated in
this chapter.
NOTE: Before attempting to perform following operations isolate the unit from the mains supply!
The activities of maintenance, cleaning and disinfection of device components should be realized at:
• ambient temperature between +15°C to +30°C,
• relative humidity between 30% to 75%,
• atmospheric pressure between 700 hPa and 1060 hPa (70 – 106 kPa).
These conditions are identical to those defined in chapter 4.2 as operation conditions.
There are no limitations for the number of cleaning and disinfection cycles, procedures should be carried out
during the entire device “life time”.
10.1 Cleaning of touchscreen

It is recommended to clean regularly the touch screen display using a microfiber cloth, preferably designated
for cleaning mirrors or electronic equipment. Gently moisten the cloth with clean water. The cloth should be
drained so that there is no dripping water. The screen should be wiped until removal of all dirt and dust.
The manufacturer does not recommend to use any product designated for cleaning screens, because there
is no guarantee that the chemicals will not lead to faster wear out of touch screen layers.
10.2 Cleaning of the unit and applicators casings

Cleaning of the unit shall be performed with lightly humid sponge or soft cloth with delicate soap solution or
mild detergent. The sponge/cloth should be drained so that there is no dripping water.
Do not use solvents for paints and lacquers. Do not use excessively dampened sponges either, which can
lead to water penetration inside the unit.
Cleaning of the applicators casings shall be performed with lightly humid sponge or soft cloth with delicate
soap solution or mild detergent. Then cleaned applicators shall be wiped with dry cloth and left for complete
drying.
10.3 Disinfection
Casing of the unit shall not be sterilized or disinfected. Disinfection of accessories, which are not intended for
contact with patient’s body (for example cables), shall be carried out with liquid or spray agents dedicated to
that purpose at least once a week.
Perform disinfection of magnetic field applicators after each treatment procedure, where there is contact with
the patient's body. It is recommended to use sanitizers based on ethanol and/or isopropyl alcohol e.g.
Alpro
Minuten Spray or 70% solution of spirit. After disinfection, accessories must be cleaned to avoid allergic
reaction.
It is not recommended to use sanitizers consisting of active oxygen, because it can lead to accessories damage.
10.4 Special messages

Table 4. Signaling special messages
Type of message Symbol
Errors
General information
Warnings
10.5 Self-test Procedure

Each time the PhysioMG unit is started, a special self-test procedure is performed during which all
modules and functional blocks of the device are tested. If any errors or damage are detected, the relevant
information will be presented on the display screen. The module where the irregularity has been
detected is blocked and the associated function is not available.
If any mistakes of the hardware nature are detected, the unit will not start. An acoustic signal reminiscent of
"tapping" will be emitted. The number of signals ("taps") generated is adequate to the number of the error (see
Table 5 of error codes). For example, if seven signals are emitted (followed by a short break), this means that
the keyboard is damaged or one of the keys is locked.
In this situation, you must disconnect the unit from the network and contact an authorized service center
for a service and a possible repair.
Table 5. The "hardware" error coding system
Error code Error description
I1 SDRAM initialization error

I2 SDRAM self-test error
I3 No communication with the SD card
I4 No communication with the TSC controller in the LCD
I5 Program defect in the processor FLASH memory (CRC)
I6 No communication with the keyboard module
I7 The keyboard is damaged or a button is pressed (a button short-circuit)
I8 Main processor oscillator error
I9 Display error in models 815 and 825

10.6 Troubleshooting
Symptoms Undertaking action

Check spare fuses. If they are blown, replace them in accordance with
The unit does not respond indications in point 10.7.
to mains supply. Try to connect different mains cable.
If the problem persists, contact your service.
Turn off and on the device.
The unit does not start. Acoustic
If the problem persists or occurs frequently, determine the type of error
sounds can be heard.
based on chapter 10.5 and contact your service.
Turn off and on the device.
Unit Error indication – symbol If the problem persists or frequently occurs, note down the error number
in the status field or channel tab. and contact your service.
Switch the unit off. Disconnect the damage accessory. Connect it once
again and switch on the mains supply.
Error indication of magnetic field If the problem persists or frequently occurs, note down the error number
applicator. and contact your service.
If you have another applicator, connect it in and check if the problem
persists.
The unit does not respond when Turn off and on the device. If the problem persists or frequently occurs,
you press keys. contact your service.
Touch screen panel doesn’t work Turn off and on the device. If the problem persists or frequently occurs,
(827 version). contact your service.
The touch panel is too sensitive or Calibrate the display. To carry out calibration, press the keys
does not respond to touch simultaneously during system startup. The unit then activates the display
(models 815 and 825). calibration mode. Follow the messages on the screen. First, touch three
The touch panel reacts in a points, then validate the correctness of operation by touching five points
different spot from where it was on the screen.
touched (models 815 and 825). See also 6.2.5.1.
Switch on the unit. Enter the setup mode. Select an appropriate language
Incomprehensible messages. version.
Unclear display. Switch on the unit. Enter the setup mode. Adjust brightness.
Switch on the unit. Enter the setup mode. Check the configuration of
Lack of buzzer signals.
buzzer volume.
Switch on the unit. Enter the setup mode. Set an appropriate buzzer
Too silent buzzer volume.
volume.
Turn off and on the device. If the problem persists or frequently occurs:
• replace the power cord,
Common message „Unit • call an expert in the scope of electrical installation to check the
diagnostic activation” quality of the protective ground connection in the power socket.
In case of low relative humidity (<30%), use a humidifier in the treatment
room.
10.7 Fuse replacement

NOTE:
Before proceeding to the further described operations isolate the unit from the mains supply!
In case of burnt fuses, they must be replaced. Their parameters are given in chapter ”Specification and
accessories” and on the name plate.

To replace fuses:
Step Description
1. Isolate the device from the mains.

2. Disconnect the mains cable from the mains socket.
3. With flat screwdriver lever the fuse socket until the moment of its slipping from the socket.
Remove the socket with your fingers, replace the fuses, install them in the socket again and press
4.
firmly.
Connect the mains cable – first to the socket placed in the rear panel of the controller and then
5.
to the mains.
6. Check the device operation.

11. Specification and accessories
11.1 Technical data

Classifications:
Medical device class: IIa
(according to MDD 93/42 / EEC and REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 5 April 2017)
Electrical safety class: I
Applied part type:
BF Degree of protection provided by enclosures:
IP20
Mode of operation:
The unit is intended for continuous operation.
Treatment parameters:
Described in chapter 8
Accuracy of operation parameters: User Manual – PhysioMG

Accuracy of induction:
Time accuracy:
User-defined programs and sequences:

User-defined programs:
User-defined sequences:
Pre-defined treatment programs:

CPEP applicator:
CP applicator:
CS35 applicator:
CS60 applicator:
CS75 applicator:
Dual mode:
Treatment timer:
Treatment time setting range:
Step, automatic adjustment:
Step, manual settings
General:
Mains supply:
Max. power consumption:
Fuses:
Unit weight:
CS35 applicator weight:
CP applicator weight:
CPEP applicator weight:
Couch weight:
Trolley weight:
Stand with CP weight:
Carrying capacity of the couch:
Carrying capacity of the shelf for the unit:
Carrying capacity of the shelf for CPEP:
±20% ±10%
50 10
45 46 28 50 50 45
max. 60 minutes 30 s
1s
230 V ±10%, 50/60 Hz 350VA

T-3,15A/250V max. 7 kg
max. 15kg (Al) / 22kg (Cu) max. 16kg
(Al) / 22kg (Cu) max. 18kg (Al) / 25kg (Cu)
max. 5,5kg
max. 2,2kg max. 47kg max.
16kg max. 29kg up to 135
kg max. 8 kg max. 3 kg
Page 52 / 58
Carrying capacity of the ST_CS trolley: max. 25 kg for every shelf

Unit dimensions (WxDxH): 340x280x110 mm
CS35 dimensions: 441x322x457 mm
CS60 dimensions: Ø682x242 mm
CS75 dimensions: Ø832x242 mm
Dimensions of one part of the CP applicator: 200x69x150 mm
Dimensions of one part of the CPEP applicator: 100x55x150 mm
Couch dimensions: 2142x532x1183 mm
Trolley dimensions: 580x500x775 mm
Dimensions of the stand area: 650x750 mm
Height adjustment range: 400-1100 mm
CP – angle of rotation 150°
Running elements (stand, trolley): 4 wheels with brakes
Storage conditions:
Temperature range: +5÷+45 °C
Relative humidity: 30÷75 %
Pressure range: 700÷1060 hPa (70 – 106 kPa)
Operation conditions:
Temperature range: +15÷+30 °C
Transport conditions:
Temperature range: -10÷+45 °C

11.2 EMC parameters

In compliance with IEC 60601-1-2:2014
Guidance and manufacturer’s declaration – electromagnetic emissions
Emission test Compliance level
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations / Flicker emissions
Complies
IEC 61000-3-3
Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test IEC60601 test level Compliance level
Electrostatic discharge (ESD) ±8 kV contact ±8 kV contact
IEC 61000-4-2 ±2, ±4, ±8, ±15 kV air ±2, ±4, ±8, ±15 kV air
Recommendation: Floor should be made of wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative
humidity should be at least 30%.

Radiated RF 10 V/m
IEC 61000-4-3 10 V/m
80MHz to 2,7 GHz
Field strengths from fixed transmitters, such base stations for radio (cellular / cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the PhysioMG unit is used exceeds the applicable RF compliance level above, the unit should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
PhysioMG unit.
Applied compliance level is suitable for home healthcare environment. It means the device may be connected to the public low-voltage
power supply network.

Electric fast transient /
burst ±2 kV ±2 kV
IEC 61000-4-4

Surges 1 kV line-to-line 1 kV line-to-line
IEC 61000-4-5 2 kV line-to-ground 2 kV line-to-ground

Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz
6 Vrms in ISM and amateur radio bands 6 Vrms in ISM and amateur radio bands
between 150 kHz – 80 MHz between 150 kHz – 80 MHz
Field strengths from fixed transmitters, such base stations for radio (cellular / cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the PhysioMG unit is used exceeds the applicable RF compliance level above, the unit should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
PhysioMG unit.
Applied compliance level is suitable for home healthcare environment. It means the device may be connected to the public low-voltage
power supply network.

Magnetic field power frequency (50/60
Hz) 30 A/m 30 A/m
IEC 61000-4-8

0% U T 0,5 cycle, phase angles of synchronization
with AC power supply voltage 0°, 45°, 90°, 135°, Complies
180°, 225°, 270°, 315°
0% U T 1 cycle, phase angle of synchronization with

Complies
Voltage dips AC power supply voltage 0°
IEC 61000-4-11 70% U T
25 cycles for 50 Hz
30 cycles for 60 Hz Complies
phase angle of synchronization with AC power
supply voltage 0°
0% U T
Voltage interruptions
250 cycles for 50 Hz Complies
IEC 61000-4-11
300 cycles for 60 Hz
Immunity test Compliance level

Proximity fields from RF wireless communications equipment according to 8.10 Page 55 / 58
IEC 60601-1-2:2014
Complies
Issue date 02.09.2019, release 10.0

11.3 Standard accessories
PhysioMG controller (depends on A-UG-AST- A-UG-AST- A-UG-AST-

1. 1 1 1
model) PMG815 PMG825 PMG827
2. Mains cable - - - 1 1 1
3. Spare fuses WTA-T 3,15 A/250V - - - 2 2 2
4. LCD touch screen cloth - - - 1 1 1
5. Pen for LCD resistive touch screen - - - 1 1
6. Pen for LCD capacitive touch screen - - - -- -
7. User Guide - - - 11 1 1
8. Electrical safety test report - - - 1 1 1
11.4 Optional accessories
Solenoid applicator CS35 A-AG-AST-CS35A

Plate applicator CPEP A-AG-AST-CPEP
Plate applicator CP A-AG-AST-CPV2
Couch LE_CS A-AG-AST-LE-CS
Trolley ST_CS A-AG-AST-ST_CS
Other
Name
Covers and belts for CPEP applicator Patient’s protective goggles
Permanent magnet

13. Appendix A
12. Appendix A. Symbol description

Symbol Definition
Caution, symbol 7000-0434A
BF type equipment, symbol IEC 60417-5333
Date of production: year, symbol ISO 7000-2497
Temperature, symbol ISO 7000-0034
Manufacturer, symbol ISO 7000-3082
IP20 Degree of protection provided by enclosures (IP code), based on IEC 60529
Fuse, symbol IEC 60417-5016
VER Unit version
Serial number, symbol ISO 7000-2498
Batch code, symbol ISO 7000-2492
Catalogue number, symbol ISO 7000-2493
Disposal of used devices together with other waste is prohibited, complied with the
requirements of WEEE
Follow operating instructions, symbol ISO 7010-M002

Background color: blue

13. Appendix A
Symbol Definition
No sitting, symbol ISO 7010-P018
Background color: white
Circular band and slash: red
Symbol or text: black
No stepping on surface, symbol ISO 7010-P019
No pushing, symbol ISO 7010-P017
No metallic articles or watches, symbol ISO 7010-P008
Non-ionizing electromagnetic radiation, symbol IEC 60417-5140
Indication of equipment in the medical electrical area that intentionally apply RF
electromagnetic energy for diagnosis or treatment.
Temperature limit, symbol ISO 7000-0632
Keep away from rain, symbol ISO 7000-0626
Fragile; handle with care, symbol ISO 7000-0621
This way up, symbol ISO 7000-0623
Weight
Packaging size
The marking of conformity with legal regulations for medical devices applicable in the
European Union along with the number of the Notified Body taking part in the
conformity assessment.

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PhysioMG –

2. INTENDED USE .........................................................................................................................................................6

Page 3 / 58 Issue date 02.09.2019, release 10.0

8.3 LIMITATION OF INDUCTION WITH FREQUENCY INCREASE .......................................................................................................... 44

List of illustrations and tables

Table 1. Available models of the PhysioMG unit........................................................................................................................

Description of symbols used in this manual:

Important notices and information.

Following texts marked with this symbol facilitates device operation.

WARNING: No modification of this equipment is allowed!

1.2 Risk management process

Page 5 / 58 Issue date 02.09.2019, release 10.0

A list of indications and contraindications is given in Chapter 9.

Complete medical product features:

Number of Applicable applicators

815 5’’ 1 CP, CS35, CS60 -

CS35, CS60, CS75, CP, CS35, CS60, CS75, CP,

User Manual – PhysioMG Page 6 / 58

2.1 Intended users

Users (operators) of PhysioMG device can be:

The user should have:

Physical and cognitive requirements of the operator:

2.2 User training

Page 7 / 58 Issue date 02.09.2019, release 10.0

3. Warranty and manufacturer's responsibility

The manufacturer is not liable in case of transmission of infection by equipment components.

The expected "life time" of the device is 10 years.

User Manual – PhysioMG Page 8 / 58

4.1 Mains supply and operation mode

Recommendations related to isolation the device from the supply mains:

Disconnection from the mains takes place after:

4.2 Storage, operation and transport conditions

The unit is intended for operation under the following conditions:

4.3 WARNINGS and safety notes

User Manual – PhysioMG Page 10 / 58

Occupational Health and Safety – magnetotherapy:

Also read the information given in chapter 9.3.

Page 11 / 58 Issue date 02.09.2019, release 10.0

4.4 Applied parts and working temperature

4.5 Explosion proof environment

4.6 Electromagnetic environment

4.7 Operation of touch-sensitive displays

Model Type of display Method of operation of the display

4.8 Technical supervision

Page 13 / 58 Issue date 02.09.2019, release 10.0

User Manual – PhysioMG Page 14 / 58

5.1 General characteristics

Figure 5.1 General view of the PhysioMG 827

Figure 5.2. General view of PhysioMG 825 and 815 units

Page 15 / 58 Issue date 02.09.2019, release 10.0

Figure 5.3 Arrangement of keyboard components on the example of PhysioMG 827

User Manual – PhysioMG Page 16 / 58

5.3 Magnetic field applicators

Figure 5.4 CS35, CS60 and CS75 solenoid applicators

Figure 5.6. CS35 applicator on the trolley

Figure 5.7. CP applicators on a stand

User Manual – PhysioMG Page 18 / 58

Figure 5.8. CPEP applicators

5.4 Name plates

Page 19 / 58 Issue date 02.09.2019, release 10.0

6. Device installation and start-up

6.1.1 Connection of magnetic field applicators

Figure 6.1 View of the PhysioMG 827 sockets label